Regulatory Affairs Manager

Jobtailor; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

Jobtailor in Sydney, Australia seeks a Senior Regulatory Affairs Leader to oversee ANZ regulatory activities, including registration, variations and lifecycle management across the portfolio.

You will develop regulatory strategies, lead and mentor the ANZ team, coordinate submissions to the TGA and Medsafe, ensure timely approvals and support market access initiatives with cross-functional partners.

Qualifications

• 8–10 years in pharmaceutical regulatory affairs with Australia & New Zealand responsibility.
• Extensive knowledge of TGA and Medsafe requirements and submissions.
• Demonstrated experience leading, mentoring regulatory professionals.
• Strong project management, prioritisation and cross-functional collaboration.

Responsibilities

• Lead regulatory function for Australia and New Zealand across product portfolio.
• Develop and implement regulatory strategies aligning with business objectives.
• Lead, coach and develop the ANZ Regulatory Affairs team.
• Oversee submissions to the TGA and Medsafe and ensure timely approvals.
• Collaborate with Commercial, Quality, Pharmacovigilance and Supply Chain.

Skills

Regulatory leadership

Stakeholder management

Project management

Communication skills

Negotiation skills

Team leadership

Organisational skills

Strategic thinking

Risk assessment

Regulatory submissions management

Education

Bachelor's Degree in Pharmacy

Bachelor's Degree in Life Sciences

Bachelor's Degree in Biomedical Science

Tools

Regulatory Dashboards

Submission Trackers

Performance Reporting Tools

Job description

• Lead the regulatory function for Australia and New Zealand and oversee registration, maintenance and compliance of the company’s product portfolio.
• Develop and implement regulatory strategies supporting business objectives and applicable legislation.
• Lead, coach and develop the ANZ Regulatory Affairs team.
• Establish priorities, allocate workloads and provide technical guidance for complex regulatory matters.
• Oversee preparation, review and submission of applications to the TGA and Medsafe.
• Ensure timely approvals for registrations, variations, notifications and renewals.
• Manage product transfers, acquisitions, divestments and lifecycle activities.
• Track and fulfil regulatory commitments, approvals and post-approval obligations.
• Provide regulatory input into commercial strategy, portfolio planning, market expansion and business development.
• Prepare regulatory risk assessments, pathway evaluations and timeline projections.
• Maintain inspection readiness and support audits.
• Contribute to quality management activities, including CAPAs, change controls and continuous improvement.
• Collaborate with Commercial, Medical Affairs, Quality, Supply Chain, Pharmacovigilance and Business Development teams.
• Advise partners, clients and external stakeholders on regulatory pathways, compliance and market access.
• Lead partner meetings, business reviews and strategic planning discussions.
• Review regulatory, pharmacovigilance, quality and technical services agreements.
• Support regulatory budgets, resource plans, invoicing and operational management.
• Develop regulatory metrics, dashboards, performance reporting and submission trackers.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Biomedical Science or a related scientific discipline.
• Minimum 8-10 years' experience in pharmaceutical regulatory affairs, including responsibility for Australia and New Zealand regulatory activities.
• Extensive knowledge of TGA and Medsafe requirements, with proven experience managing regulatory submissions across the product lifecycle.
• Demonstrated experience leading, developing and mentoring regulatory professionals.
• Strong strategic thinking, with the ability to assess regulatory risks, opportunities and commercial implications to support business decisions.
• Experience supporting business planning, portfolio strategy, due diligence and evaluation of new product opportunities.
• Strong project management, organisational and prioritisation skills.
• Excellent communication, presentation, stakeholder management and negotiation skills.
• Ability to analyse and communicate complex scientific, regulatory and commercial information to technical and non-technical audiences.
• Strong commercial awareness and the ability to balance business objectives with regulatory compliance requirements.
• Demonstrated ability to build trusted relationships with senior stakeholders, clients, partners and regulatory authorities.
• Experience supporting business development activities, client engagements, business case evaluations and commercial decision-making.
• Ability to contribute effectively as a member of an Extended Leadership Team, driving organisational objectives, collaboration and continuous improvement.

Core Competencies

Demonstrates extensive knowledge of TGA and Medsafe requirements, with a strong background in pharmaceutical regulatory affairs and a proven ability to lead and develop regulatory teams. Capable of strategic thinking and risk assessment to align regulatory compliance with business objectives.

Highest-signal resume keywords

• Regulatory Affairs Leadership
• TGA and Medsafe Compliance
• Regulatory Submissions Management
• Strategic Risk Assessment
• Project Management

Hard Skills

• Regulatory Strategy Development
• Regulatory Risk Assessment
• Regulatory Submissions
• Product Lifecycle Management
• Quality Management Activities
• Regulatory Metrics Development
• Pharmacovigilance
• Change Control
• Continuous Improvement
• Market Access Compliance

Soft Skills

• Communication Skills
• Stakeholder Management
• Negotiation Skills
• Team Leadership
• Organisational Skills

Certifications & Qualifications

• Bachelor's Degree in Pharmacy
• Bachelor's Degree in Life Sciences
• Bachelor's Degree in Biomedical Science

Industry Keywords

• Pharmaceutical Regulatory Affairs
• Australia and New Zealand Regulatory Activities
• Commercial Strategy
• Business Development
• Inspection Readiness

Tools & Technologies

• Regulatory Dashboards
• Submission Trackers
• Performance Reporting Tools